NCT04358549

Study of the Use of Favipiravir in Hospitalized Subjects With COVID-19

Open Label, Randomized, Controlled Phase 2 Proof-of-Concept Study of the Use of Favipiravir Compared to Standard of Care in Hospitalized Subjects With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine the effect of favipiravir + SOC v. SOC on COVID-19 viral clearance.

Detailed description

This is an open label, randomized, controlled, multicenter Phase 2 proof-of-concept study of favipiravir in hospitalized subjects with Corona Virus Disease (COVID) -19. Subjects will be randomized within their study site and stratified by the severity of their disease to receive either favipiravir + standard of care (SOC) or SOC alone. The dose regimen will be 1800 mg favipiravir bis in die (BID) plus SOC or SOC alone on Day 1 followed by 1000 mg BID favipiravir (800 mg BID for subjects with Child-Pugh A liver impairment) plus SOC or SOC for the next 13 days. The study will have 14 days of treatment and 46 days of follow-up. Approximately 50 patients are planned to be enrolled in the trial at approximately 8 study sites in the US.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Favipiravir	Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets
OTHER	Standard of Care	Standard of Care for individual study site as determined by each hospital's protocol

Timeline

• Start date: 2020-04-17
• Primary completion: 2020-09-30
• Completion: 2020-10-30
• First posted: 2020-04-24
• Last updated: 2022-03-29
• Results posted: 2022-03-29

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study